How do I find out if my device is affected by the recall?

Check the model numbers MFM-CNS and MFM-CNS Lite against the recall list provided by Edan Diagnostics.

Will I receive a refund for the recalled device?

Yes, follow the recall instructions for the refund process. You do not need a receipt to obtain a refund.

What are the risks of using the recalled monitoring system?

Using the recalled devices may expose patient data to cybersecurity threats, potentially compromising sensitive information.

How long will it take to process my refund?

Refund processing typically takes 4-6 weeks after your device is returned.

Can I still use my device if it seems to be functioning correctly?

No, you should stop using the device immediately, regardless of its current functionality, due to potential cybersecurity issues.

How will I be notified about the recall?

You will receive a notification letter from Edan Diagnostics regarding the recall and instructions for returning the device.

Is there any information on the specific cybersecurity issues?

The details of the cybersecurity issues have not been disclosed, but they are significant enough to warrant a recall.

Where can I find more information about the recall?

Visit the FDA recall page at the provided link for detailed information and updates.

What if my healthcare provider doesn't have information about the recall?

Contact Edan Diagnostics directly for guidance if your healthcare provider is not aware of the recall.

HIGHOctober 24, 2025

EDAN Central Monitoring System Recalled Over Cybersecurity Issues

EDAN recalled 395 units of its Central Monitoring System on October 24, 2025, due to potential cybersecurity risks. The affected models include MFM-CNS and MFM-CNS Lite, which manage critical fetal and maternal health data. Healthcare providers must stop using the devices immediately and follow the recall instructions.

Quick Facts at a Glance

Recall Date: October 24, 2025
Hazard Level: HIGH
Brand: Edan Diagnostics
Category: Health & Personal Care
Sold At: Multiple Retailers
Geographic Scope: 1 states
At-Risk Groups: GENERAL

Hazard Information

As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device.

What You Should Do

Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Edan Diagnostics or your healthcare provider for instructions. Notification method: Letter

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Product Details

The recalled models are MFM-CNS and MFM-CNS Lite. They were distributed worldwide, including in California, Kentucky, Puerto Rico, Florida, Connecticut, Illinois, Pennsylvania, Rhode Island, North Carolina, New York, Louisiana, Texas, Michigan, and Mexico.

The Hazard

The recall stems from an FDA It Has Come to Our Attention Letter regarding potential cybersecurity issues. These vulnerabilities could compromise patient data security.

Reported Incidents

No injuries or incidents have been reported as a result of this issue. The recall is classified as Class II, indicating a high risk of harm.

What to Do

Stop using the device immediately. Contact Edan Diagnostics or your healthcare provider for further instructions and follow the recall instructions provided.

Contact Information

For more information, contact Edan Diagnostics at their official website or through the FDA recall page at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-1151-2026.

Key Facts

Recalled models: MFM-CNS, MFM-CNS Lite
Total units recalled: 395
Distributed in U.S. and Mexico
Cybersecurity vulnerabilities identified

View Original Recall on FDA - Medical Devices

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Safety Assessment

Risk LevelHIGH

Severity Score

8/ 10

Affected Groups

GENERAL

Injury Types

OTHER

Product Classification

CategoryHealth & Personal Care › Medical Devices

Product TypeClinical Data Managing Software

Product Details

Brand

Edan Diagnostics

Categories

Health & Personal Care Medical Devices

Model Numbers

EDAN Model: MFM-CNS UDI-DI code: 06944413800236 Serial/Lot Numbers: 460793-M18C12290001 460793-M19109170001 460793-M19200240001 460793-M19411950001 460793-M19804210001 460793-M19912750001 460793-M19B07530001 460793-M20809190001 460793-M20913190002 460793-M20913190001 460793-M20B19040001 460793-M21600070001 460793-M21603510001 460793-M24702870002 460793-M24702870001 460793-M25203640001 460793-M25314460001 460793-M25314460002 460793-M25610650001 460793-M25610650003 460793-M25610650002 EDAN Model: MFM-CNS Lite UDI-DI code: 06944413807983 Serial/Lot Numbers: 460570-M19710380001 460570-M19710370001 460570-M19A06460005 460570-M19A06460006 460570-M19A06460007 460570-M19A06460015 460570-M19A06460008 460570-M19A06460009 460570-M19A06460001 460570-M19A06460011 460570-M19A06460003 460570-M19A06460004 460570-M19A06460010 460570-M19A06460002 460570-M19A06460012 460570-M19A06460013 460570-M19A06460014 460570-M20602690001 460570-M20602690003 460570-M20602690002 460570-M20700020009 460570-M20700020002 460570-M20700020011 460570-M20700020012 460570-M20700020005 460570-M20700020007 460570-M20700020013 460570-M20700020008 460570-M20700020003 460570-M20700020004 460570-M20700020001 460570-M20700020010 460570-M20700020006 460570-M20807880003 460570-M20807880005 460570-M20807880001 460570-M20807880002 460570-M20807880004 460570-M20A08380001 460570-M20A08380004 460570-M20A08380005 460570-M20A08380002 460570-M20A08380003 460570-M20C16310008 460570-M20C16310009 460570-M20C16310010 460570-M20C16310004 460570-M20C16310006 460570-M20C16310001 460570-M20C16310002 460570-M20C16310003 460570-M20C16310005 460570-M20C16310007 460570-M24814460001 460570-M24814460002 460570-M24814460004 460570-M24814460003 460570-M24814460005 460570-M24B06920003 460570-M24B06920001 460570-M24B06920004 460570-M24B06920002 460570-M24B06920005 460570-M25216230002 460570-M25216230004 460570-M25216230005 460570-M25216230001 460570-M25216230006 460570-M25407560001 460570-M25407560002 460570-M25511390003 460570-M25511390001 460570-M25511390004 460570-M25511390002 461334-M25321000004 461334-M25321000008 461334-M25321000014 461334-M25321000019 461334-M25321000022 461334-M25321000034 461334-M25321000039 461334-M25321000055 461334-M25321000068 461334-M25321000070 461334-M25321000077 461334-M25321000090 461334-M25321000097 461335-M25320990002 461335-M25320990026 461335-M25320990051 461335-M25320990062 461335-M25320990068 461335-M25320990070 461335-M25320990074 461335-M25320990077 461335-M25320990086 461335-M25320990090 461335-M25320990092 461335-M25320990098 461335-M25320990108 461335-M25320990121 461335-M25320990132 461335-M25320990136 461335-M25320990138 461335-M25320990139 461335-M25320990152 461335-M25320990156 461335-M25320990157 461335-M25320990159 461335-M25320990181 461334-M25321000015 461334-M25321000029 461334-M25321000035 461334-M25321000044 461334-M25321000049 461334-M25321000053 461334-M25321000056 461334-M25321000060 461334-M25321000067 461334-M25321000075 461334-M25321000083 461334-M25321000087 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461335-M25320990052 461335-M25320990066 461335-M25320990081 461335-M25320990096 461335-M25320990113 461335-M25320990114 461335-M25320990124 461335-M25320990143 461335-M25320990144 461335-M25320990158 461335-M25320990161 461335-M25320990165 461335-M25320990187 461335-M25320990191 461335-M25320990195 461334-M25321000005 461334-M25321000018 461334-M25321000038 461334-M25321000050 461334-M25321000057 461334-M25321000065 461334-M25321000081 461334-M25321000082 461334-M25321000086 461334-M25321000095 461335-M25320990001 461335-M25320990016 461335-M25320990023 461335-M25320990025 461335-M25320990031 461335-M25320990046 461335-M25320990060 461335-M25320990064 461335-M25320990067 461335-M25320990073 461335-M25320990075 461335-M25320990079 461335-M25320990094 461335-M25320990097 461335-M25320990102 461335-M25320990106 461335-M25320990107 461335-M25320990109 461335-M25320990111 461335-M25320990115 461335-M25320990120 461335-M25320990125 461335-M25320990137 461335-M25320990141 461335-M25320990145 461335-M25320990170 461335-M25320990184 461334-M25321000002 461334-M25321000011 461334-M25321000012 461334-M25321000031 461334-M25321000032 461334-M25321000040 461334-M25321000047 461334-M25321000084 461334-M25321000088 461335-M25320990005 461335-M25320990021 461335-M25320990033 461335-M25320990035 461334-M25321000001 461334-M25321000003 461334-M25321000006 461334-M25321000013 461334-M25321000016 461334-M25321000025 461334-M25321000033 461334-M25321000036 461334-M25321000045 461334-M25321000061 461334-M25321000062 461334-M25321000079 461334-M25321000085 461335-M25320990006 461335-M25320990010 461335-M25320990012 461335-M25320990018 461335-M25320990036 461335-M25320990053 461335-M25320990057 461335-M25320990059 461335-M25320990071 461335-M25320990080 461335-M25320990084 461335-M25320990088 461335-M25320990100 461335-M25320990105 461335-M25320990112 461335-M25320990116 461335-M25320990118 461335-M25320990119 461335-M25320990127 461335-M25320990040 461335-M25320990042 461335-M25320990048 461335-M25320990055 461335-M25320990082 461335-M25320990101 461335-M25320990122 461335-M25320990126 461335-M25320990128 461335-M25320990129 461335-M25320990131 461335-M25320990150 461335-M25320990155 461335-M25320990173 461335-M25320990174 461335-M25320990182 461335-M25320990186 461335-M25320990188 461335-M25320990189 461335-M25320990130 461335-M25320990135 461335-M25320990142 461335-M25320990146 461335-M25320990148 461335-M25320990149 461335-M25320990163 461335-M25320990164 461335-M25320990177 461335-M25320990193 461335-M25320990194 461334-M25321000020 461334-M25321000023 461334-M25321000027 461334-M25321000043 461334-M25321000054 461334-M25321000059 461334-M25321000072 461334-M25321000089 461334-M25321000091 461334-M25321000092 461335-M25320990013 461335-M25320990015 461335-M25320990019 461335-M25320990024 461335-M25320990027 461335-M25320990029 461335-M25320990043 461335-M25320990045 461335-M25320990049 461335-M25320990061 461335-M25320990087 461335-M25320990089 461335-M25320990091 461335-M25320990110 461335-M25320990133 461335-M25320990140 461335-M25320990153 461335-M25320990154 461335-M25320990167 461335-M25320990172 461335-M25320990176 461335-M25320990178 461335-M25320990179 461335-M25320990197 461334-M25321000009 461334-M25321000021 461334-M25321000026 461334-M25321000041 461334-M25321000042 461334-M25321000046 461334-M25321000058 461334-M25321000064 461334-M25321000069 461334-M25321000071 461334-M25321000073 461334-M25321000076 461334-M25321000093 461334-M25321000096 461335-M25320990014 461335-M25320990017 461335-M25320990020 461335-M25320990022 461335-M25320990028 461335-M25320990044 461335-M25320990047 461335-M25320990056 461335-M25320990072 461335-M25320990078 461335-M25320990083 461335-M25320990085 461335-M25320990103 461335-M25320990104 461335-M25320990134 461335-M25320990151 461335-M25320990162 461335-M25320990166 461335-M25320990168 461335-M25320990169 461335-M25320990180 461335-M25320990185 461335-M25320990192 461335-M25320990196 461335-M25320990198 461335-M25320990199 461335-M25320990200

Affected States

ALL

Report Date

January 28, 2026

Source Agency

FDA - Medical Devices

Recall Status

ACTIVE

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